Efficacy and tolerability of Citrus/Cydonia comp.® 1% solution for injection in patients with grass pollen seasonal allergic rhinitis: A randomised, double-blind, placebo-controlled clinical trial - The CiSAR Study

Weleda AG0 个研究点目标入组 120 人开始时间: 2010年2月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Written informed consent
•Age = 18 and < 60 years.
•Seasonal allergic rhinitis:
•-Duration of respective complaints at least 2 years
•-RAST for grass pollen: = 2
•-Positive skin prick test on grass pollen
•-Suffering from the following symptoms:
•sneezing, itching nose, nasal obstruction and watery nasal discharge
•-Severity score of at least two of the four symptoms = 2; ranging from 0 = not present to 3 = severe.
•-The necessity to use antihistamines and/or corticosteroids for treatment of symptoms for at least two previous years
•- Average Total Symptom Score in the wash-out period = 9 on days with a pollen count > 20 or use of rescue medication on days with a pollen count > 20
•Healthy volunteers:
•Written informed consent
•Age = 18 and < 60 years
•RAST for seasonal AR related grass and birch pollen = 0
•No history of seasonal AR symptoms for at least 2 years
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Chronic autoimmune disease such as Diabetes Mellitus type 1, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn’s disease
•Known hypersensitivity to one of the constituents of Citrus/Cydonia comp.®
•Participation in a further clinical trial at the same time or within 4 weeks prior to enrolment into this study
•Previous use of medicinal products containing Citrus and/or Cydonia
•Pregnancy or lactation
•Severe internal or systemic disease (e.g. cardiac, hepatic, renal diseases)
•A known history of drug, alcohol and/or medication dependence or addiction
•Immunotherapy in the last two years
•Other allergies (no seasonal AR)
•Healthy volunteers:
•Nasal seasonal AR related symptoms during the pollen season: sneezing, itching nose, nasal obstruction and watery nasal discharge
•Chronic inflammatory autoimmune disease such as Diabetes Mellitus type 1, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn’s disease
•Participation in a further clinical trial at the same time or within 4 weeks prior to enrolment into this study.
•Pregnancy or lactation
•Severe internal or systemic disease ( e.g. cardiac, hepatic, renal diseases)
•A known history of drug, alcohol and/or medication dependence or addiction
•Immunotherapy in the last two years
•Other allergies (no seasonal AR)

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